BRAF-/MEK-Inhibition With Dabrafenib and Trametinib in Melanoma Patients

  • STATUS
    Recruiting
  • End date
    Jul 11, 2023
  • participants needed
    250
  • sponsor
    EuMelaReg gGmbH
Updated on 11 February 2021
cancer
melanoma skin
BRAF
trametinib
immunomodulators
dabrafenib
immunologic adjuvant
malignant melanoma of skin

Summary

Adjuvant therapy with dabrafenib plus trametinib in melanoma was approved in 2018 by the EMA (EUropean Medicines Agency).

The purpose of this non-interventional study is to assess the usage of adjuvant dabrafenib and trametinib in clinical practice, where the patient population may differ from study population.

Description

Melanoma is a disease of significant metastatic potential if not detected very early. Oncogenic mutations in BRAF (B-Raf proto-oncogene, serine/threonine kinase) are found in approximately 40% of melanomas and result in constitutive activation of the MAPK (Mitogen-Activated Protein Kinase) pathway.

Treatment with the BRAF inhibitor dabrafenib plus the MEK (Mitogen-activated protein kinase kinase) inhibitor trametinib showed improved overall survival in patients with unresectable or metastatic BRAF V600E/K-mutant melanoma (COMBI-d and COMBI-v studies). In an adjuvant setting treatment with dabrafenib and trametinib significantly reduced the risk of melanoma recurrence in patients with high-risk, stage III BRAF V600-mutant melanoma, with improvements in OS (Overall Survival), DMFS (Distant Metastasis Free Survival), and FFR (Freedom From Relaps) (COMBI-AD study). Based on these results, adjuvant dabrafenib plus trametinib therapy was approved in 2018 by the EMA.

Compared to the metastatic situation, issues of compliance and treatment adherence may be more relevant in adjuvant treatments, as patients are free of disease and potentially cured even without adjuvant treatment. As the routine administration of drugs including dosing, treatment interruptions, and early termination in clinical practice may vary from procedures defined in clinical trials, this study aims to assess the usage of adjuvant dabrafenib and trametinib in the routine clinical setting.

Details
Condition melanoma, skin cancer, Metastatic Melanoma, Malignant Melanoma
Treatment dabrafenib and trametinib
Clinical Study IdentifierNCT03944356
SponsorEuMelaReg gGmbH
Last Modified on11 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Metastatic Melanoma or Malignant Melanoma or skin cancer or melanoma?
Do you have any of these conditions: Malignant Melanoma or skin cancer or melanoma or Metastatic Melanoma?
Do you have any of these conditions: melanoma or skin cancer or Malignant Melanoma or Metastatic Melanoma?
Patients with complete surgical resection of histologically confirmed AJCC (American Joint Committee on Cancer) (8th edition) clinical stage III (IIIA, IIIB, IIIC, IIID) melanoma, for whom a decision for adjuvant treatment with dabrafenib and trametinib has been made before entering the study
V600E/K mutation-positive cutaneous melanoma
Adjuvant treatment with combination therapy of Dabrafenib (Tafinlar) and Trametinib (Mekinist) as indicated in the SmPC (Summary of Product Characteristics) and by prescription, that has been started no longer that 4 weeks before inclusion of the patient into the study or which will be initiated directly after inclusion
Age 18 years
Signed written informed consent

Exclusion Criteria

Lack of basic demographics and staging information
Current or planned participation within a clinical trial. The participation in a follow-up phase of a clinical trial without active intervention is allowed
Current or planned treatment of another tumor disease except keratoacanthoma, squamous cell or basal cell carcinoma of the skin
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